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临床试验/CTRI/2024/06/069035
CTRI/2024/06/069035招募中3 期

Effectiveness of slow cortical potential neurofeedback in comparison to stimulant medication methylphenidate on behavioral outcomes in children with attention deficit hyperactivity disorder.

Ritambhara Mandal1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年6月25日最近更新:

试验速览

阶段
3 期
状态
招募中
发起方
入组人数
60
试验地点
1
主要终点
Neurofeedback is effective on behavioural outcomes of ADHD in comparison to stimulant medication ,according to conners 3 parent short scale

研究概览

简要总结

This study is a randomized , parallel group trial where 60 childrens diagnosed with ADHD will be divided into two groups, one group will receive neurofeedback along with stimulant medication and another group will receive only stimulant medication that is methylphenidate . There will be 24 sessions and each session will be of 16 minutes .follow up will be done after 3 months as per conners 3 parent short scale . Primary outcome measures how much effective the neurofeedback is in comparison to stimulant medication.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
6.00 Year(s) 至 12.00 Year(s)(—)
性别
All

入选标准

  • Aged 6 to 12 years 2) Fulfilling the diagnostic criteria according to DSM 5 3)Fulfilling the criteria of CONNERS 3AI, ADHD Indicator scale as screening tool 4) Children with no contraindication for methylphenidate 5) parents are willing to give informed consent on behalf of their children and compliant to therapy.

排除标准

  • Children with Intellectual deficit disorder and Autism spectrum disorder 2) Any neurological like seizure disorder or physical illness 3) Any other significant psychiatric illness like mood disorder ,psychosis ,obsessive compulsive disorder.

结局指标

主要结局

Neurofeedback is effective on behavioural outcomes of ADHD in comparison to stimulant medication ,according to conners 3 parent short scale

时间窗: 3 months

次要结局

  • Neurofeedback improves inattention, hyperactivity, impulsivity, executive function, defiance or aggression and peer relation in children with ADHD(3 months)

研究者

发起方
Ritambhara Mandal
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Ritambhara Mandal

Institute of Psychiatry

研究点 (1)

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